Calcitriol

Evidence Level: L5 Predicted Indications: 5

Table of Contents

  1. Calcitriol
    1. Pharmacist Assessment Report
    2. Calcitriol: active vitamin D hormone (vitamin D receptor agonist) → obsolete vitamin D deficiency
    3. One-Sentence Summary
    4. Quick Overview
    5. Why is This Prediction Reasonable?
    6. Clinical Trial Evidence
    7. Literature Evidence
    8. Canada Market Information
    9. Safety Considerations
    10. Conclusion and Next Steps
    11. Disclaimer

Pharmacist Assessment Report

Calcitriol: active vitamin D hormone (vitamin D receptor agonist) → obsolete vitamin D deficiency

One-Sentence Summary

Calcitriol is the active hormonal form of vitamin D and is marketed in Canada as a single-ingredient product. The TxGNN model predicts it may be useful for obsolete vitamin D deficiency, with a prediction score of 0.9996. There are currently no clinical trials and no publications retrieved for this specific prediction, so it rests on model output alone.

Quick Overview

Item Content
Original Indication Not recorded in the local data
Predicted New Indication obsolete vitamin D deficiency
TxGNN Prediction Score 0.9996
Evidence Level L5
Canada Market Status Marketed (marketed DINs: 6 of 8; dormant: 1; cancelled: 1)
Number of DINs 8 (marketed: 6)
Recommended Decision Hold

Why is This Prediction Reasonable?

Detailed mechanism-of-action data are not available in the data compiled for this report. Calcitriol is, however, the biologically active form of vitamin D (1,25-dihydroxyvitamin D3). It acts through the vitamin D receptor to regulate calcium and phosphate handling. A biological link to vitamin D deficiency is therefore plausible, and this is likely why the model scores the prediction so highly.

Three points weaken the case:

  • The disease term is flagged as obsolete in the disease vocabulary, so it may not correspond to a clearly defined current clinical condition.
  • Calcitriol is already the activated hormone. Nutritional vitamin D deficiency is generally treated with native vitamin D (cholecalciferol or ergocalciferol) rather than calcitriol.
  • No trials or literature were retrieved to show that calcitriol benefits patients with this condition.

Clinical Trial Evidence

Currently no related clinical trials registered.

Literature Evidence

Currently no related literature available.

Canada Market Information

The main authorizations are listed below. Approved indication text and dosage forms are not recorded in the local data.

DIN Product Name
00481823 ROCALTROL
00481815 ROCALTROL
02485710 TARO-CALCITRIOL
02485729 TARO-CALCITRIOL
02431645 CALCITRIOL-ODAN

Safety Considerations

  • Drug Interactions (100 interacting drugs were identified; the main ones are listed):
    • Major: cholecalciferol, calcifediol and burosumab. Combining active or native vitamin D forms raises the risk of excess vitamin D effect and hypercalcaemia. Burosumab is a major interaction because it changes phosphate and vitamin D handling.
    • Moderate:
      • Thiazide diuretics (hydrochlorothiazide, chlorothiazide, chlorthalidone, bendroflumethiazide, benzthiazide) can raise calcium levels.
      • Enzyme-inducing anticonvulsants and barbiturates (carbamazepine, fosphenytoin, amobarbital, butabarbital, butalbital) can lower vitamin D activity.
      • Bile acid sequestrants (cholestyramine, colesevelam, colestipol) can reduce absorption.
      • Digoxin and digitoxin carry arrhythmia risk if calcium rises.
      • Aluminum hydroxide and topical calcipotriol also interact.

Package insert warnings and contraindications for the Canadian products were not available in the data compiled for this report. Please refer to the package insert for further safety information.

Conclusion and Next Steps

Decision: Hold

Rationale: The score is very high, but the prediction has no supporting trials or publications. The disease term is obsolete, and native vitamin D rather than calcitriol is the usual treatment for nutritional deficiency. This places it at evidence level L5.

To proceed, the following is needed:

  • Clarification of which current, non-obsolete disease concept this prediction maps to
  • Clinical or literature evidence directly studying calcitriol in that condition, including comparison against native vitamin D
  • Mechanism-of-action data
  • Package insert warnings and contraindications from Health Canada, to support a safety screen (hypercalcaemia and the interactions above)

    Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.

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